Precision Spine AccuFit® ALIF Plate System. Catalog #01-F5525

Vendor/Manufacturer: Precision Spine

Product/Product Line: AccuFit® ALIF Plate System

Vendor/Manufacturer Catalog #: 01-F5525

Global Unique Device (GUD) Primary Device Identifier Number: 00840019912587

Global Unique Device (GUD) Device Description:

5.5mm X 25mm Self Drilling Fixed Screw

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Category 1: Spine

Category 2: Thoracolumbar Plate & Screw Systems

Category 3: Screw

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission: K091044

The Precision Spine AccuFit® ALIF Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:

1. Spinal USA Anterior Lumbar Plate System

For more information, please visit us at Infonomics.com